Dukal Corp.
FDA Regulatory Profile
Dukal Corp. appears in FDA public data with 3 recalls, 13 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0233-2018, Class II) was initiated on June 1, 2017. Its most recent 510(k) clearance was granted on May 28, 2026.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 13
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0233-2018 | Class II | BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a ster | June 1, 2017 |
| D-1676-2012 | Class II | Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v, Item 854-1000 | June 14, 2012 |
| D-1675-2012 | Class II | ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), | June 14, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252823 | Dukal Crepe Paper Sterilization Wrap | May 28, 2026 |
| K233262 | Dukal SMS Sterilization Wrap | March 22, 2024 |
| K083320 | DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE | March 6, 2009 |
| K070407 | DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELL | March 26, 2007 |
| K061864 | DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 | September 15, 2006 |
| K020726 | DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE | May 15, 2002 |
| K984564 | ETHYL CHLORIDE DISPENSER | December 2, 1999 |
| K970457 | DUKAL ABD COMBINE PAD | May 8, 1997 |
| K970455 | DUKAL NON ADHERENT DRESSING | May 8, 1997 |
| K955476 | DUKAL TRANSPARENT WOUND DRESSING | January 18, 1996 |
| K940440 | DUKAL NON-WOVEN GAUZE | March 9, 1994 |
| K936095 | GAUZE SPONGE | February 2, 1994 |
| K931005 | DUKAL SKIN CLOSURE STRIP | July 14, 1993 |